Spring Intro 2023

30/03/2023

Regulatory Strategy Session

A series of short interactive discussions led by Neil Roberts, Gilead and David Kane, Vertex

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning outcomes

Understand Regulatory Strategic Aspects of Following Topics:

• Initial Considerations + setting the framework • Understand the bigger picture and strategic thinking • Think Global • US, EU, beyond EU (GB post Brexit) and key considerations for Worldwide Markets • Regulatory/HTA Advice • Paediatric Development & PIPs • Orphan disease considerations • Accelerating Access (Expedited Pathways) • Tradename • IP and exclusivity considerations

The Organisation for Professionals in Regulatory Affairs

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